BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    IMPRA CARBOFLO EPTFE VASCULAR GRAFTS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    artegral life HD

    FDA UDI
    Merz Dental GmbH·D7092004012·artegral life HighDefinition posterior upper -M...

    Minit®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333468·

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20040120·2.0mm Cortex Screw, 1.5 Hex, Self-Tapping, 12mm

    Minuteman G3

    FDA UDI
    Spinal Simplicity, LLC·M9431000040120·MIS Fusion Plate

    APOLLO Ankle Fracture Plating System

    FDA UDI
    Glw, Inc.·18435711003320·APOLLO Ankle Fracture Plates / 1/3 Tubular Plat...

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·January 23, 2025

    IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VISION R/F TILTING TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD® WHITACRE SPINAL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·November 28, 2022

    LEVEL 1

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code LGZ·August 27, 2019

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·Product code FPA·May 15, 2024

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·Product code FPA·May 15, 2024

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·Product code FPA·May 15, 2024

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code OYC·January 30, 2009

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORP·Product code LZG·February 23, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 26, 2008

    BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.

    FDA Enforcement
    Class II ·Ongoing·RONAN MEDICAL LLC·September 4, 2024

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DYB·April 28, 2014

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025